(117 days)
No
The description focuses on synthesizing data and displaying alerts based on predefined limits and thresholds, which were determined through literature review and expert consensus, not through AI/ML training. There is no mention of learning or adaptive algorithms.
No.
The device is for secondary monitoring and alerting clinicians, not for direct diagnosis or treatment. It instructs users to refer to primary monitors before making clinical decisions.
No.
AlertWatch:OR is explicitly described as a "secondary monitoring" and "secondary alert system" that synthesizes data from other primary monitors. Users are instructed to "refer to the primary monitor or device before making a clinical decision," indicating that it provides information for monitoring but does not directly make a diagnosis or inform a treatment decision without further confirmation from primary sources. This suggests it is a monitoring and alert system, rather than a diagnostic device that confirms a medical condition.
Yes
The device description explicitly states that AlertWatch:OR is a "display and secondary alert system" and a "program" that synthesizes data. The modifications described are to "display views, user features, indicators and alerts" and compatibility with the iPad and iPhone, all of which are software-related. There is no mention of any hardware component being part of the device itself, only that it connects to existing physiological monitors and AIMS systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that AlertWatch:OR is for "secondary monitoring of patients within operating rooms" and by "supervising anesthesiologists outside of operating rooms." It combines data from existing medical devices (physiologic monitors, AIMS) and patient records. This is focused on real-time patient monitoring and data aggregation, not on analyzing biological samples to diagnose or detect diseases or conditions.
- Device Description: The description reinforces its role as a "display and secondary alert system" that "synthesizes a wide range of patient data." It explicitly states that clinicians must refer to the primary monitor or device before making a clinical decision. This indicates it's a tool to aid in clinical decision-making based on existing data, not a diagnostic test itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, AlertWatch:OR is a clinical decision support and monitoring system that integrates and displays data from other medical devices. It does not perform diagnostic testing on biological samples, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.
AlertWatch:OR is also intended for use by supervising anesthesiologists outside of operating rooms. Once alerted, the supervising anesthesiologist must contact the clinician inside the operating room or must return to the operating room before making a clinical decision. Once either clinician is alerted, they must refer to the primary monitor or device before making a clinical decision.
Product codes
MWI
Device Description
AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff residents. CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with AlertWatch:OR. AlertWatch, LLC performs the validation for each installation site.
The purpose of this 510(k) is for marketing clearance of AlertWatch:OR 2.50 which includes minor modifications to some display views, user features, indicators and alerts as well as compatibility with the iPad and the iPhone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: Anesthesiologist, Resident, CRNA
Intended Use environment: OR - referred to primary monitor for clinical decision. The mobile AlertWatch application can be installed on a personal iPhone or used via safari on an iPad for use by supervising anesthesiologists outside of operating rooms, who are connected to the hospital network.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Human Factors Study: The iPhone version of AlertWatch:OR has a different user interface than the desktop product. To better understand any potential usability issues that could interfere with the intended use of the product. AlertWatch performed a comprehensive human factors study. The iPad version did not require a human factors study, because the layout and input methodology was the same as the predicate version (assuming a touch screen PC in the operating room).
- Default Limits and Thresholds: AlertWatch, Inc. used a three-phased approach to ensure that the default limits were clinically valid:
-
- Review of References. AlertWatch sought out definitive published studies that highlighted appropriate limits for certain patient conditions. This includes limits and thresholds for the green/yellow/red organ schema, as well as the alerts and formulae.
-
- Expert Committee. When references were not available, AlertWatch sought out the opinion and confirmation of anesthesia physicians at the University of Michigan Health System. Each of these clinicians reviewed the limits, provided feedback, and reviewed the final results.
-
- External Experts. AlertWatch obtained final review of the default limits from an external group of four anesthesiology experts.
-
- IEC 60601-1-8: A summary of how AlertWatch:OR addresses the primary issues identified in IEC 60601-1-8 is provided in the submission.
- Usability Study demonstrated that users were able to successfully complete critical tasks in a simulated use environment.
- Wireless coexistence testing demonstrated that the system could operate correctly in an environment with other wireless devices.
- Software verification testing demonstrated that the software met all requirements and performed as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other. The profiles are stylized and connected by flowing lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
Alertwatch LLC % Donna-Bea Tillman Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street Suite 100 Alexandria, Virginia 22314
Re: K153335
Trade/Device Name: Alertwatch: OR Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: February 16, 2016 Received: February 18, 2016
Dear Donna-Bea Tillman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153335
Device Name AlertWatch: OR
Indications for Use (Describe)
AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.
AlertWatch:OR is also intended for use by supervising anesthesiologists outside of operating rooms. Once alerted, the supervising anesthesiologist must contact the clinician inside the operating room or must return to the operating room before making a clinical decision. Once either clinician is alerted, they must refer to the primary monitor or device before making a clinical decision.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY - K153335
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the AlertWatch:OR is provided below.
| Device Common Name: | Physiological Patient Monitor without arrhythmia
detection or alarms |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | AlertWatch:OR |
| Applicant: | AlertWatch, LLC
1600 Huron Pkwy, Bldg. 520, Ste. 2326
Ann Arbor, MI 48109 |
| Contact: | Justin Adams, CEO
AlertWatch, LLC
Phone: 734-998-8344
Email: Justin.adams@alertwatch.com |
| Prepared by: | Donna-Bea Tillman
Senior Consultant
Biologics Consulting Group, Inc.
Phone: 410-531-6542
Fax: 720-293-0014
Email: dtillman@bcg-usa.com |
| Date Prepared: | November 18, 2015 |
| Classification Regulation: | 21 CFR 870.2300 - Cardiac monitor (including
cardiotachometer and rate alarm) |
| Panel: | Cardiovascular |
| Product Code: | MWI |
| Predicate Device: | K130401, AlertWatch: OR, AlertWatch, LLC |
Indication for Use:
AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.
AlertWatch:OR is also intended for use by supervising anesthesiologists outside of operating rooms. Once alerted, the supervising anesthesiologist must contact the clinician inside the
4
operating room or must return to the operating room before making a clinical decision. Once either clinician is alerted, they must refer to the primary monitor or device before making a clinical decision.
Device Description:
AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff residents. CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with AlertWatch:OR. AlertWatch, LLC performs the validation for each installation site.
The purpose of this 510(k) is for marketing clearance of AlertWatch:OR 2.50 which includes minor modifications to some display views, user features, indicators and alerts as well as compatibility with the iPad and the iPhone.
Performance Data:
- . Human Factors Study: The iPhone version of AlertWatch:OR has a different user interface than the desktop product. To better understand any potential usability issues that could interfere with the intended use of the product. AlertWatch performed a comprehensive human factors study. The iPad version did not require a human factors study, because the layout and input methodology was the same as the predicate version (assuming a touch screen PC in the operating room).
- . Default Limits and Thresholds: AlertWatch, Inc. used a three-phased approach to ensure that the default limits were clinically valid:
-
- Review of References. AlertWatch sought out definitive published studies that highlighted appropriate limits for certain patient conditions. This includes limits and thresholds for the green/yellow/red organ schema, as well as the alerts and formulae.
-
- Expert Committee. When references were not available, AlertWatch sought out the opinion and confirmation of anesthesia physicians at the University of Michigan Health System. Each of these clinicians reviewed the limits, provided feedback, and reviewed the final results.
-
- External Experts. AlertWatch obtained final review of the default limits from an external group of four anesthesiology experts.
-
- IEC 60601-1-8: A summary of how AlertWatch:OR addresses the primary issues identified in IEC 60601-1-8 is provided in the submission.
5
Substantial Equivalence:
Primary Predicate -The cleared AlertWatch:OR (K130401) is provided as a primary predicate device in terms of Indications for Use and technological characteristics.
Reference Device - Per the FDA Guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2104, the cleared Amcom CommTech Messenger (K112047) is provided as a reference device to support the use of paging to include alerts that originate from AlertWatch:OR.
The table below compares the key technological features of the subject device to the primary predicate device (AlertWatch: OR K130401).
| Predicate Device | Proposed Device | |
|---|---|---|
| Device Name | AlertWatch:OR (v2.48) | AlertWatch:OR (v2.50) |
| 510(k) number | K130401 | K153335 |
| Classification | MWI | MWI |
| Regulation | 870.2300 | 870.2300 |
| Indications for Use | AlertWatch:OR is intended for use by | |
| clinicians for secondary monitoring of | ||
| patients within operating rooms. | ||
| AlertWatch:OR combines data from | ||
| networked physiologic monitors. | ||
| anesthesia information management | ||
| systems and patient medical records | ||
| and displays them in one place. | ||
| AlertWatch:OR can only be used with | ||
| both physiological monitors and AIMS | ||
| versions that have been validated by | ||
| AlertWatch. Once alerted, you must | ||
| refer to the primary monitor or device | ||
| before making a clinical decision. | AlertWatch:OR is intended for use by | |
| clinicians for secondary monitoring of | ||
| patients within operating rooms. | ||
| AlertWatch:OR combines data from | ||
| networked physiologic monitors, anesthesia | ||
| information management systems and | ||
| patient medical records and displays them | ||
| in one place. AlertWatch:OR can only be | ||
| used with both physiological monitors and | ||
| AIMS versions that have been validated by | ||
| AlertWatch. Once alerted, you must refer to | ||
| the primary monitor or device before | ||
| making a clinical decision. | ||
| AlertWatch:OR is also intended for use by | ||
| supervising anesthesiologists outside of | ||
| operating rooms. Once alerted, the | ||
| supervising anesthesiologist must contact | ||
| the clinician inside the operating room or | ||
| must return to the operating room before | ||
| making a clinical decision. Once either | ||
| clinician is alerted, they must refer to the | ||
| primary monitor or device before making a | ||
| clinical decision. | ||
| Intended Use | ||
| environment | OR - referred to primary monitor for | |
| clinical decision. | OR - referred to primary monitor for | |
| clinical decision. | ||
| The mobile AlertWatch application can be | ||
| installed on a personal iPhone or used via | ||
| safari on an iPad for use by supervising | ||
| anesthesiologists outside of operating | ||
| rooms, who are connected to the hospital | ||
| Predicate Device | Proposed Device | |
| network. | ||
| Intended Users | Anesthesiologist, Resident, CRNA | Identical |
| Data server | AlertWatch:OR accesses physiologic | |
| data from the hospital network, and all | ||
| other data from the AIMS database | ||
| server. | Identical | |
| Supported AIMS | ||
| systems | GE Centricity 7.63 | Centricity, version 7.6.3 |
| Picis / Optum, version 421 | ||
| iMDsoft / Metavision, version 5.46.44 | ||
| Supported physiological | ||
| monitors | GE Solar 9500 | |
| GE Carespan B850 | Identical | |
| Hardware platforms | ||
| supported | PC | PC, iPad, iPhone |
| Generates clinical | ||
| advisories | AlertWatch:OR Alerts analyzes data | |
| from patient monitors and other | ||
| sources and alerts when values exceed | ||
| preset limits. | AlertWatch:OR Alerts analyzes data from | |
| patient monitors and other sources and | ||
| alerts when values exceed preset limits. | ||
| There are been some changes to the content | ||
| of these advisories (see Section 11.9 and | ||
| 11.10) | ||
| Re-display of vital sign | ||
| data from primary | ||
| monitors | Yes | Yes |
| Intended to replace | ||
| primary monitors | No | No |
| Paging | Yes. For clinicians to page each other | |
| using the hospital-established paging | ||
| system. | Yes. For clinicians to page each other and | |
| for AlertWatch:OR to transmit alerts using | ||
| the hospital-established paging system. | ||
| Uses color to display | ||
| clinical information | Image: Predicate device color display | Image: Proposed device color display |
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Substantial Equivalence Conclusion:
The subject AlertWatch:OR (v2.50) is modification of the previously cleared device (K130401) that adds several new features that do not alter the fundamental intended use of the device as a secondary monitor for patients in the operating room. The indications for use are identical to the predicate device.
7
The modified alerts and changes to the display of information, and the addition of an iPhone version, do not raise different questions of safety or effectiveness when compared to the primary predicate device. A Usability Study demonstrated that users were able to successfully complete critical tasks in a simulated use environment. Wireless coexistence testing demonstrated that the system could operate correctly in an environment with other wireless devices. Software verification testing demonstrated that the software met all requirements and performed as expected. Therefore, AlertWatch:OR (v2.50) can be found substantially equivalent to the previously cleared AlertWatch:OR (v2.48).